Recently, the medical institution serviced by Beijing CytoNicheTech Co., Ltd. (hereinafter referred to as "CytoNiche") CDMO platform sent samples for inspection. CytoNiche's three-dimensional cell culture technology (3D TableTrix® microcarriers + large-scale 3D FloTrix® vivaSIPIN bioreactors) was used for fully enclosed large-scale preparation of umbilical cord mesenchymal stem cells. After quality reassessment by the China Food and Drug Testing Institute (referred to as "NIFDC"), it officially received the "Inspection Report" (Number: SH202311161), becoming the first case in China to be quality reassessed by NIFDC based on 3D microcarrier culture for human mesenchymal stem cells. (Previously, CytoNiche's 3D TableTrix® microcarriers had also passed NIFDC's relevant quality and safety assessments.)

[Certification of authority]

NIFDC is a drug specialized technical organization directly under the State Food and Drug Administration, responsible for drug registration testing required by law and other related work. It is a nationally accredited testing laboratory with laboratory accreditation (CNAS) and qualification accreditation (CMA). NIFDC is the statutory organization for drug and biological product quality testing and the highest technical arbitration body in China. This cell quality "Inspection Report" involves comprehensive multi-item testing in four major areas of cell quality, including 39 testing items, covering basic biological properties, microbiological safety, biological safety, and biological efficacy. The test results confirm that umbilical cord mesenchymal stem cells prepared with 3D TableTrix® microcarriers meet all requirements.

In terms of basic biological properties: Cell identification, cell viability testing, interspecies cell contamination testing, and chromosomal karyotype analysis all meet the requirements.

In terms of safety: Aseptic testing, mycoplasma testing, endogenous and exogenous virus testing, and tumorigenicity testing all meet the requirements.

In terms of efficacy: Evaluations of multi-lineage differentiation functionality and immunomodulatory functionality demonstrate that umbilical cord mesenchymal stem cells have directed differentiation and immunomodulatory capabilities.

Obtaining NIFDC quality certification is considered one of the important basic conditions for conducting clinical research on stem cell therapy products. This signifies that umbilical cord mesenchymal stem cells prepared on a large scale with CytoNiche's 3D microcarriers and vivaSPIN bioreactors have met the clinical application standards in terms of basic biological properties, microbiological safety, biological safety, and efficacy. It also demonstrates the safety, stability, and reliability of CytoNiche's 3D FloTrix® cell culture technology, preparation process, and production quality control.

[Critical path]

Under the dual-track regulatory system for stem cell clinical research in China, whether it is for the record of stem cell clinical research projects (Non-IND) or for the purpose of applying for implied approval for stem cell drug clinical trials (IND), the preparation of stem cell therapy products should follow the "Drug Production Quality Management Specification" (GMP). The preparation of stem cell preparations must also comply with the "Guiding Principles for Quality Control and Preclinical Research of Stem Cell Preparations."

According to the "Administrative Measures for Clinical Research on Stem Cells" and the "Guiding Principles for Quality Control and Preclinical Research of Stem Cell Preparations" in China, stem cell clinical research is currently regulated by the National Health Commission and the National Medical Products Administration. Ethical requirements for clinical research: Based on the prepared stem cell therapy product, a quality reassessment report issued by a third-party testing institution must be obtained before conducting subsequent preclinical pharmacology and toxicology studies. 

[CytoNiche's Billion-Level Stem Cell Preparation ]

Based on the 3D TableTrix® microcarriers and 3D FloTrix® cell culture technology, CytoNiche, with the assistance of a series of cell culture, harvesting, and filling equipment, has constructed a groundbreaking "billion-level" stem cell production plan. The entire production process employs a fully enclosed, automated process that allows for real-time cell counting and quality monitoring. Cell amplification cultivation can reach billions within 13 days, and the final cell preparations comply with strict quality control and repository standards.

Additionally, CytoNiche can design customized stem cell three-dimensional amplification cultivation processes to meet different cell culture requirements based on the growth characteristics of mesenchymal stem cells from various tissues, achieving a breakthrough in both "quality" and "quantity" of cell production.

3D TableTrix® Microcarriers: 3D TableTrix® microcarriers provide an ideal microenvironment for cell growth and differentiation, better simulating the growth environment and complex cell-tissue interactions in the human body and having the ability to create tissue-like structures in vitro. The quality of umbilical cord mesenchymal stem cells prepared with 3D TableTrix® microcarriers meets the quality control standards for stem cell preparations in the "Guiding Principles for Quality Control and Preclinical Research of Stem Cell Preparations." All three-dimensional amplification process parameters have been repeatedly verified to ensure the stability of stem cell preparation processes for different cell types.

3D FloTrix® Cell Technology Platform: Based on the 3D FloTrix® cell technology platform, CytoNiche provides services including CMC process design for stem cell pharmaceutical research, two-dimensional cell culture process research and cell preparation, three-dimensional cell culture process research and cell preparation, stem cell preparation amplification plans, establishment of quality testing items, testing methods, and standards for various levels of cell repositories, and establishment of cell preparation production process systems and quality standard systems.

[CytoNiche's Support Services]

 ▷ If you are conducting research related to projects using 3D TableTrix® Microcarrier and need to submit applications to the FDA such as Investigational New Drug (IND) or New Drug Application (NDA), you can contact the relevant sales department to apply. CytoNiche Biotech will provide you with an authorization letter that allows the FDA to directly review the technical content of the DMF involved during drug application review, helping to expedite the FDA review process.

▷ If you're interested in CytoNiche Biotech's 3D TableTrix® Microcarrier, you can also scan the code to apply for a trial.

【CytoNiche】

Beijing CytoNiche Biotechnology Co., Ltd. was established by the research team of Professor Du Yanan from Tsinghua University School of Medicine, and was jointly established by Tsinghua University through equity participation. The core technologies were derived from the transformation of scientific and technological achievements of Tsinghua University. CytoNiche focuses on building an original 3D cell "smart manufacturing" platform, as well as providing overall solutions for the 3D microcarrier-based customized cell amplification process.

Products and services of CytoNiche can be widely used in the upstream process development of gene and cell therapy, extracellular vesicles, vaccines, and protein products. At the same time, it also has broad prospects for applications in the fields of regenerative medicine, organoids, and food technology (cell-cultured meat, etc.).

Our company has a R&D and transformation platform of 5,000 square meters, including a CDMO platform of more than 1,000 square meters, a GMP production platform of 4,000 square meters, and a new 1200 L microcarrier production line. The relevant technologies have obtained more than 100 patents and more than 30 articles about the technologies in international journals have been published. The core technology projects have obtained a number of national-level project support and applications.